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An investigation was performed for the reported customer complaint: ¿the customer reported a burn of the skin, about 2 millimeters and non-continuous, was made along the black band of the electrode after defibrillation of 360 joules.The customer further reports that flamazine ointment was prescribed as a result.¿ no lot number was provided.A review of the device history report (dhr) was unable to be performed.Because there was no lot number, a date of manufacture could not be determined.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.One (1) sample was received from the customer for evaluation.The sample consisted of the defibrillator electrodes.The electrode set pouch was not returned with the sample.The two (2) pads were stuck to a plastic binder sleeve (non-silicone coated).The defibrillator electrode sets was visually evaluated.All components were present and the defibrillator electrode sets were constructed per the product specifications.However, it was noted that there was some missing gel in the center of one (1) of the pads.The customer did not provide any details as to if the missing gel was present when the electrode was used on the patient.The printed silver pattern on the conductive gel bodies met the acceptance criteria.The connector wire sets were inspected for compromised insulation, no issues were observed.The electrode set gel was somewhat dried out as they were not contained in a pouch and stuck to a non-silicone (coated) piece of plastic.It was also noted that there was some hair (1-2¿ in length) along the edge of one of the pads.The returned sample was subjected to an array of tests in accordance with internal inspection protocol for defibrillator properties.The results were within the acceptance criteria to completely satisfy the manufacturing requirements per the product specification, except for the impedance value.The value was elevated.However, this is not unusual (but expected) for electrodes that are not sealed within a protective pouch.As stated above, the electrodes were stuck to a piece of plastic and were somewhat dried out (not sticky to the touch).No pictures of the burns/redness were provided with the complaint.Therefore, an evaluation could not be performed to definitively confirm the burn (skin irritation) was typical of what a patient might experience using a defibrillation electrode product in a defibrillation procedure.In the relation to the missing gel in on the electrodes, this is called delamination.This type of event is commonly referred to gel delamination.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.Delamination is categorized as follows: an aesthetic delamination defect is characterized by a permanent separation of the hydrogel from the substrate, exposing the underlying carbon vinyl with little (i.E.Area less than 1/8 inch x 1/8 inch) or no hydrogel remains on the release liner.Also, no silver/silver chloride ink is exposed.Aesthetic delamination defects will not significantly affect electrode function, but may displease the clinician.Functional delamination is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.Additionally, when the release liner is removed from the electrode, there shall be no more than no more than 45% hydrogel separation from the adult electrode.When the area of separation includes the area of underlying conductive mat, the maximum amount of hydrogel lost is 22% for adult electrodes.With loss of the hydrogel less than the percentages as defined above the electrodes retain functionally essential performance; however the reduction in the hydrogel area with the silver/silver chloride ink being exposed may cause an increase in current density across the remaining gel area.This increases the potential for skin irritation and burns.The gel that was missing does not appear to be the root cause of the issue described by the customer (missing gel was less than 22%).The burn described by the customer was along the edge of the electrode, not localized in the center where the missing gel was.The described burn was most likely that of which can be expected from the energy applied through the electrodes.It is important to note that these electrodes provide a reduced skin irritation, but do not eliminate skin irritation.Erythemas, burns, and even blisters while not desirable, are not an uncommon consequence of defibrillation/cardioversion.Defibrillation/cardioversion requires high intensity electrical energy to be delivered to the body through the skin, which generates heat at the contact site.Repeated shocks of escalating energy, often required for a successful defibrillation/cardioversion, will exacerbate the undesirable side effects of therapy.It should be noted that conductive printed gradient design reduces the probability and extent of irritation resulting from defibrillation, but it does not eliminate it.It is important that the operator be thoroughly familiar with the electrode operating instructions and warnings prior to use.Failure to comply with the product instructions for use or warnings may increase the likelihood of a patient exhibiting skin irritation.Care should be taken to properly prepare the patient¿s skin prior to electrode application.Special consideration should be given to the electrodes and wires while working around a patient or moving a patient so that the electrodes are not damaged.To help the electrode make good skin contact and to help reduce contact impedance, the product labeling instructions and warnings should be followed.The instructions advise/warn: remove excess hair.Clean and dry skin sites.Do not use alcohol or tincture of benzoin.Position electrodes per the figures provided on the packaging.If possible, do not place electrodes on broken skin.Smooth the electrode from the center outward to the edges with fingertips to ensure that there are no air pockets between the gel and the patient's skin.Electrodes are not repositionable.Replace with new electrodes if repositioning is required.This will ensure optimal adhesion and min imize potential patient skin burns.Remove the electrodes from the patient by slowly peeling pad from the patient¿s skin.Do not discharge hand-held available.Do not open package until immediately prior to use.Do not use if electrode or pouch is damaged.Important: replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.Use separate ecg electrodes when performing noninvasive pacing.In addition, all hydrogels manufactured as this facility must comply with iso standards.Skin reaction such as those experienced by the patient could be the result of an acute sensitization response to the material components that make up the electrode.All materials have been deemed safe and effective for use per the iso standards.The results of the investigation were unable to attribute any root causes associated with the manufacture of product which would have paddles through these electrodes.A potential root cause could include patient skin sensitivity to the gel or adhesive foam component of the electrode.Biocompatibility studies are performed on the adhesive foam and gels according to the guidelines defined in the iso standards.Each gel and electrode manufactured in the facility must pass cytotoxicity, primary skin irritation and skin sensitization testing before it is distributed for commercial sale.Each hydrogel offered for sale have passed all three tests to ensure the highest quality medical hydrogels contributed to the susceptibility of skin irritation.The reported customer complaint is not confirmed.A root cause could not be determined.Based upon the investigative details and the root cause evaluation, no further corrective or preventative actions will be taken at this time in relation to the customer described event.This complaint will be utilized for tracking and trending purposes.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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